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A Global Study to Assess the Effects of MEDI4736 (Durvalumab), Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer (ARCTIC)

Primary Purpose

Non - Small Cell Lung Cancer NSCLC

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

MEDI4736 (durvalumab)

Vinorelbine

Gemcitabine

Erlotinib

MEDI4736 (durvalumab) in combination with tremelimumab (anti-CTLA4)

tremelimumab (anti-CTLA4)

About this trial

This is an interventional treatment trial for Non - Small Cell Lung Cancer NSCLC

Eligibility Criteria

18 Years - 130 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Aged at least 18 years
Documented evidence of NSCLC (Stage IIIB/ IV disease)
Disease progression or recurrence after both a platinum-based chemotherapy regimen and at least 1 additional regimen for treatment of NSCLC
World Health Organization (WHO) Performance Status of 0 or 1
Estimated life expectancy more than 12 weeks

Exclusion Criteria:

Prior exposure to any anti-PD-1 or anti-PD-L1 antibody or anti-CTLA4
Brain metastases or spinal cord compression unless asymptomatic, treated and stable (not requiring steroids)
Active or prior documented autoimmune disease within the past 2 years
Evidence of severe or uncontrolled systemic disease, including active bleeding diatheses or active infections including hepatitis B, C and HIV
Any unresolved toxicity CTCAE (Common Terminology Criteria of Adverse Events) >Grade 2 from previous anti-cancer therapy
Known EGFR TK activating mutations or ALK rearrangements
Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1
Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

MEDI4736 (durvalumab) monotherapy in Sub-study A

Standard of Care in Sub-study A

MEDI4736 (durvalumab) + tremelimumab in Sub-study B

Standard of Care in Sub-study B

MEDI4736 (durvalumab) monotherapy in Sub-study B

tremelimumab in Sub-study B

Arm Description

MEDI4736 (durvalumab) by intravenous infusion. Sub-study A for patients with PD-L1 positive tumors.

Investigator choice from Vinorelbine, Gemcitabine and Erlotinib. Sub-study A for patients with PD-L1 positive tumors.

MEDI4736 (durvalumab) by intravenous infusion and tremelimumab by intravenous infusion. Sub-study B for patients with PD-L1 negative tumors.

Investigator choice from Vinorelbine, Gemcitabine and Erlotinib. Sub-study B for patients with PD-L1 negative tumors.

MEDI4736 (durvalumab) by intravenous infusion. Sub-study B for patients with PD-L1 negative tumors.

tremelimumab by intravenous infusion. Sub-study B for patients with PD-L1 negative tumors.

Outcomes

Primary Outcome Measures

Overall Survival (OS)

The OS was defined as the time from the date of randomization until death due to any cause.

Progression-Free Survival (PFS)

The PFS was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anti-cancer therapy prior to progression. The PFS was determined by Investigator assessments according to response evaluation criteria in solid tumours (RECIST) version 1.1. PD was defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 millimeter (mm) or progression of non-target lesions or the appearance of a new lesion

Secondary Outcome Measures

OS, Contribution of the Components Analysis of Sub-study B

The OS was defined as the time from the date of randomization until death due to any cause.

Percentage of Participants Alive at 12 Months (OS12)

The OS12 was defined as the percentage of participants who were alive at 12 months after randomisation per Kaplan-Meier estimate of OS at 12 months.

PFS, Contribution of the Components Analysis of Sub-study B

The PFS was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anti-cancer therapy prior to progression. The PFS was determined by Investigator assessments according to RECIST v1.1. PD was defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 millimeter (mm) or progression of non-target lesions or the appearance of a new lesion

Objective Response Rate (ORR)

The ORR was defined as the percentage of participants with at least 1 visit response of complete response (CR) or partial response (PR) among ITT participants who had measurable disease at baseline. CR was defined as disappearance of all target lesions (any pathological lymph nodes selected as target lesions must have a reduction in short axis to <10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum of diameters as long as criteria for PD are not met). The ORR was measured using Investigator assessments according to RECIST v1.1.

Duration of Response (DoR)

The DoR was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression. The DoR was determined by Investigator assessments according to RECIST v1.1. PD was defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 millimeter (mm) or progression of non-target lesions or the appearance of a new lesion

Percentage of Participants Alive and Progression Free at 6 Months (APF6)

The APF6 was defined as the percentage of participants who were alive and progression free per RECIST v1.1 at 6 months after randomization per Kaplan-Meier estimate of PFS at 6 months. PD was defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 millimeter (mm) or progression of non-target lesions or the appearance of a new lesion

Percentage of Participants Alive and Progression Free at 12 Months (APF12)

The APF12 was defined as the percentage of participants who were alive and progression free per RECIST v1.1 at 12 months after randomization per Kaplan-Meier estimate of PFS at 12 months. PD was defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 millimeter (mm) or progression of non-target lesions or the appearance of a new lesion

Time From Randomisation to Second Progression (PFS2) of Sub-study B

The PFS2 was defined as the time from the date of randomization to the earliest of the progression event subsequent to that used for the PFS endpoint or death and determined by local standard clinical practice and have included any of the following: objective radiological, symptomatic progression, or death. PFS2 was reported for sub-study B only.

Full Information

NCT ID

NCT02352948

First Posted

January 28, 2015

Last Updated

October 3, 2023

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT02352948

Brief Title

A Global Study to Assess the Effects of MEDI4736 (Durvalumab), Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer

Acronym

ARCTIC

Official Title

A Phase III, Open Label, Randomised, Multi-centre, International Study of MEDI4736, Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV) Who Have Received at Least Two Prior Systemic Treatment Regimens Including One Platinum Based Chemotherapy Regimen and Do Not Have Known EGFR TK Activating Mutations or ALK Rearrangements (ARCTIC).

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

January 13, 2015 (Actual)

Primary Completion Date

February 9, 2018 (Actual)

Study Completion Date

August 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study is a Phase III, randomised, open label, multi-centre study assessing the efficacy and safety of MEDI4736 (durvalumab) versus Standard of Care in NSCLC patients with PD-L1 positive tumours and the combination of MEDI4736 (durvalumab) plus tremelimumab (MEDI4736+treme) versus Standard of Care in NSCLC patients with PD-L1-negative tumours in the treatment of male and female patients with locally advanced or metastatic NSCLC (Stage IIIB-IV), who have received at least 2 prior systemic treatment regimens including 1 platinum-based chemotherapy regimen for NSCLC. Patients with known EGFR (Epidermal growth factor receptor) tyrosine kinase (TK) activating mutations and anaplastic lymphoma kinase (ALK) rearrangements are not eligible for the study (prospective testing is not planned within this study). The Standard of Care options are: an EGFR tyrosine kinase inhibitor (erlotinib [TARCEVA®]), gemcitabine or vinorelbine (NAVELBINE®)

Detailed Description

The study has an umbrella design with 2 sub-studies: sub-study A (randomizing patients with PD-L1 positive tumours 1:1 into MEDI4736 (durvalumab) vs. Standard of Care) and sub-study B (randomizing patients with PD-L1 negative tumours 2:3:1:2 into MEDI4736 (durvalumab) vs. MEDI4736 (durvalumab) plus tremelimumab vs. tremelimumab vs. Standard of Care. The two substudies may have different durations of recruitment periods due to differences in patient population (PD-L1 expression). They may not run concurrently with start and completion of recruitment potentially occurring at different time points.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non - Small Cell Lung Cancer NSCLC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

597 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MEDI4736 (durvalumab) monotherapy in Sub-study A

Arm Type

Experimental

Arm Description

MEDI4736 (durvalumab) by intravenous infusion. Sub-study A for patients with PD-L1 positive tumors.

Arm Title

Standard of Care in Sub-study A

Arm Type

Active Comparator

Arm Description

Investigator choice from Vinorelbine, Gemcitabine and Erlotinib. Sub-study A for patients with PD-L1 positive tumors.

Arm Title

MEDI4736 (durvalumab) + tremelimumab in Sub-study B

Arm Type

Experimental

Arm Description

MEDI4736 (durvalumab) by intravenous infusion and tremelimumab by intravenous infusion. Sub-study B for patients with PD-L1 negative tumors.

Arm Title

Standard of Care in Sub-study B

Arm Type

Active Comparator

Arm Description

Investigator choice from Vinorelbine, Gemcitabine and Erlotinib. Sub-study B for patients with PD-L1 negative tumors.

Arm Title

MEDI4736 (durvalumab) monotherapy in Sub-study B

Arm Type

Experimental

Arm Description

MEDI4736 (durvalumab) by intravenous infusion. Sub-study B for patients with PD-L1 negative tumors.

Arm Title

tremelimumab in Sub-study B

Arm Type

Experimental

Arm Description

tremelimumab by intravenous infusion. Sub-study B for patients with PD-L1 negative tumors.

Intervention Type

Drug

Intervention Name(s)

MEDI4736 (durvalumab)

Intervention Description

MEDI4736 (durvalumab) treatment by intravenous infusion

Intervention Type

Drug

Intervention Name(s)

Vinorelbine

Intervention Description

Vinorelbine by intravenous infusion. Administered at a dose of 30 mg/m2 iv on Days 1, 8, 15 and 22 of a 28-day cycle.

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Intervention Description

Gemcitabine by intravenous infusion. Administered at a dose of 1000 mg/m2 iv over 30 minutes on Days 1, 8, and 15 of a 28-day cycle.

Intervention Type

Drug

Intervention Name(s)

Erlotinib

Intervention Description

Erlotinib administered at a dose of 150 mg once daily as a tablet for oral administration

Intervention Type

Drug

Intervention Name(s)

MEDI4736 (durvalumab) in combination with tremelimumab (anti-CTLA4)

Intervention Description

MEDI4736 (durvalumab) in combination with tremelimumab (anti-CTLA4) treatment by intravenous infusion

Intervention Type

Drug

Intervention Name(s)

tremelimumab (anti-CTLA4)

Intervention Description

tremelimumab (anti-CTLA4) treatment by intravenous infusion

Primary Outcome Measure Information:

Title

Overall Survival (OS)

Description

The OS was defined as the time from the date of randomization until death due to any cause.

Time Frame

From randomization (Day 1) until death due to any cause, approximately 36 months

Title

Progression-Free Survival (PFS)

Description

Time Frame

Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 3 years.

Secondary Outcome Measure Information:

Title

OS, Contribution of the Components Analysis of Sub-study B

Description

The OS was defined as the time from the date of randomization until death due to any cause.

Time Frame

From randomization (Day 1) until death due to any cause, approximately 36 months

Title

Percentage of Participants Alive at 12 Months (OS12)

Description

The OS12 was defined as the percentage of participants who were alive at 12 months after randomisation per Kaplan-Meier estimate of OS at 12 months.

Time Frame

From randomization (Day 1) up to 12 months

Title

PFS, Contribution of the Components Analysis of Sub-study B

Description

The PFS was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anti-cancer therapy prior to progression. The PFS was determined by Investigator assessments according to RECIST v1.1. PD was defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 millimeter (mm) or progression of non-target lesions or the appearance of a new lesion

Time Frame

Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 3 years.

Title

Objective Response Rate (ORR)

Description

Time Frame

Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 3 years.

Title

Duration of Response (DoR)

Description

Time Frame

Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 3 years.

Title

Percentage of Participants Alive and Progression Free at 6 Months (APF6)

Description

Time Frame

Tumour scans performed at baseline then every ~8 weeks up to 6 months

Title

Percentage of Participants Alive and Progression Free at 12 Months (APF12)

Description

Time Frame

Tumour scans performed at baseline then every ~8 weeks up to 12 months.

Title

Time From Randomisation to Second Progression (PFS2) of Sub-study B

Description

Time Frame

Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until first progression. Disease then assessed per local practice until 2nd progression. Assessed up to a maximum of approximately 3 years.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

130 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Aged at least 18 years Documented evidence of NSCLC (Stage IIIB/ IV disease) Disease progression or recurrence after both a platinum-based chemotherapy regimen and at least 1 additional regimen for treatment of NSCLC World Health Organization (WHO) Performance Status of 0 or 1 Estimated life expectancy more than 12 weeks Exclusion Criteria: Prior exposure to any anti-PD-1 or anti-PD-L1 antibody or anti-CTLA4 Brain metastases or spinal cord compression unless asymptomatic, treated and stable (not requiring steroids) Active or prior documented autoimmune disease within the past 2 years Evidence of severe or uncontrolled systemic disease, including active bleeding diatheses or active infections including hepatitis B, C and HIV Any unresolved toxicity CTCAE (Common Terminology Criteria of Adverse Events) >Grade 2 from previous anti-cancer therapy Known EGFR TK activating mutations or ALK rearrangements Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1 Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Stockman, MBChB, PhD

Organizational Affiliation

AstraZeneca

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85224

Country

United States

Facility Name

Research Site

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Research Site

City

Duarte

State/Province

California

ZIP/Postal Code

91010

Country

United States

Facility Name

Research Site

City

La Jolla

State/Province

California

ZIP/Postal Code

92093

Country

United States

Facility Name

Research Site

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Research Site

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Research Site

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33901

Country

United States

Facility Name

Research Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32804

Country

United States

Facility Name

Research Site

City

Port Saint Lucie

State/Province

Florida

ZIP/Postal Code

34952

Country

United States

Facility Name

Research Site

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33705

Country

United States

Facility Name

Research Site

City

Athens

State/Province

Georgia

ZIP/Postal Code

30607

Country

United States

Facility Name

Research Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Research Site

City

Lawrenceville

State/Province

Georgia

ZIP/Postal Code

30046

Country

United States

Facility Name

Research Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Research Site

City

Waterloo

State/Province

Iowa

ZIP/Postal Code

50701

Country

United States

Facility Name

Research Site

City

Ashland

State/Province

Kentucky

ZIP/Postal Code

41101

Country

United States

Facility Name

Research Site

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20850

Country

United States

Facility Name

Research Site

City

Battle Creek

State/Province

Michigan

ZIP/Postal Code

49017

Country

United States

Facility Name

Research Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63156

Country

United States

Facility Name

Research Site

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68506

Country

United States

Facility Name

Research Site

City

Bronx

State/Province

New York

ZIP/Postal Code

10461-2375

Country

United States

Facility Name

Research Site

City

Mineola

State/Province

New York

ZIP/Postal Code

11501

Country

United States

Facility Name

Research Site

City

New York

State/Province

New York

ZIP/Postal Code

10011

Country

United States

Facility Name

Research Site

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Research Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Facility Name

Research Site

City

Pinehurst

State/Province

North Carolina

ZIP/Postal Code

28374

Country

United States

Facility Name

Research Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45242

Country

United States

Facility Name

Research Site

City

West Chester

State/Province

Ohio

ZIP/Postal Code

45069

Country

United States

Facility Name

Research Site

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37404

Country

United States

Facility Name

Research Site

City

Germantown

State/Province

Tennessee

ZIP/Postal Code

38138

Country

United States

Facility Name

Research Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Research Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84106

Country

United States

Facility Name

Research Site

City

Spokane

State/Province

Washington

ZIP/Postal Code

99208

Country

United States

Facility Name

Research Site

City

Murdoch

ZIP/Postal Code

6150

Country

Australia

Facility Name

Research Site

City

Port Macquarie

ZIP/Postal Code

2444

Country

Australia

Facility Name

Research Site

City

Charleroi

ZIP/Postal Code

6000

Country

Belgium

Facility Name

Research Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Research Site

City

Libramont-Chevigny

ZIP/Postal Code

6800

Country

Belgium

Facility Name

Research Site

City

Mons

ZIP/Postal Code

7000

Country

Belgium

Facility Name

Research Site

City

Roeselare

ZIP/Postal Code

8800

Country

Belgium

Facility Name

Research Site

City

Yvoir

ZIP/Postal Code

5530

Country

Belgium

Facility Name

Research Site

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1330

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1407

Country

Bulgaria

Facility Name

Research Site

City

Varna

ZIP/Postal Code

9010

Country

Bulgaria

Facility Name

Research Site

City

Moncton

State/Province

New Brunswick

ZIP/Postal Code

E1C 6Z8

Country

Canada

Facility Name

Research Site

City

Saint John

State/Province

New Brunswick

ZIP/Postal Code

E2L 4L2

Country

Canada

Facility Name

Research Site

City

Santiago

ZIP/Postal Code

7500000

Country

Chile

Facility Name

Research Site

City

Santiago

ZIP/Postal Code

8420383

Country

Chile

Facility Name

Research Site

City

Temuco

ZIP/Postal Code

4810469

Country

Chile

Facility Name

Research Site

City

Nova Ves pod Plesi

ZIP/Postal Code

262 04

Country

Czechia

Facility Name

Research Site

City

Praha 2

ZIP/Postal Code

128 08

Country

Czechia

Facility Name

Research Site

City

Praha 5

ZIP/Postal Code

150 06

Country

Czechia

Facility Name

Research Site

City

Avignon Cedex 9

ZIP/Postal Code

84918

Country

France

Facility Name

Research Site

City

Bayonne

ZIP/Postal Code

64100

Country

France

Facility Name

Research Site

City

Brest Cedex

ZIP/Postal Code

29609

Country

France

Facility Name

Research Site

City

Creteil

ZIP/Postal Code

94010

Country

France

Facility Name

Research Site

City

Le Mans

ZIP/Postal Code

72000

Country

France

Facility Name

Research Site

City

Marseille Cedex 20

ZIP/Postal Code

13915

Country

France

Facility Name

Research Site

City

Montpellier Cedex

ZIP/Postal Code

34295

Country

France

Facility Name

Research Site

City

Nice

ZIP/Postal Code

06100

Country

France

Facility Name

Research Site

City

Pau Cedex

ZIP/Postal Code

64046

Country

France

Facility Name

Research Site

City

Saint Herblain

ZIP/Postal Code

44805

Country

France

Facility Name

Research Site

City

Toulon

ZIP/Postal Code

83100

Country

France

Facility Name

Research Site

City

Villejuif

ZIP/Postal Code

94800

Country

France

Facility Name

Research Site

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Research Site

City

Berlin

ZIP/Postal Code

10967

Country

Germany

Facility Name

Research Site

City

Berlin

ZIP/Postal Code

12351

Country

Germany

Facility Name

Research Site

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Research Site

City

Gauting

ZIP/Postal Code

82131

Country

Germany

Facility Name

Research Site

City

Halle

ZIP/Postal Code

06120

Country

Germany

Facility Name

Research Site

City

Hamburg

ZIP/Postal Code

22081

Country

Germany

Facility Name

Research Site

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Research Site

City

Homburg

ZIP/Postal Code

66421

Country

Germany

Facility Name

Research Site

City

Köln

ZIP/Postal Code

51109

Country

Germany

Facility Name

Research Site

City

Löwenstein

ZIP/Postal Code

74245

Country

Germany

Facility Name

Research Site

City

Regensburg

ZIP/Postal Code

93053

Country

Germany

Facility Name

Research Site

City

Trier

ZIP/Postal Code

54290

Country

Germany

Facility Name

Research Site

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

Research Site

City

Villingen-Schwenningen

ZIP/Postal Code

78052

Country

Germany

Facility Name

Research Site

City

Athens

ZIP/Postal Code

11527

Country

Greece

Facility Name

Research Site

City

Thessaloniki

ZIP/Postal Code

54645

Country

Greece

Facility Name

Research Site

City

Thessaloniki

ZIP/Postal Code

57010

Country

Greece

Facility Name

Research Site

City

Hong Kong

Country

Hong Kong

Facility Name

Research Site

City

Miskolc

ZIP/Postal Code

3529

Country

Hungary

Facility Name

Research Site

City

Törökbálint

ZIP/Postal Code

2045

Country

Hungary

Facility Name

Research Site

City

Zalaegerszeg

ZIP/Postal Code

8000

Country

Hungary

Facility Name

Research Site

City

Zalaegerszeg

ZIP/Postal Code

8900

Country

Hungary

Facility Name

Research Site

City

Tel Hashomer

ZIP/Postal Code

52621

Country

Israel

Facility Name

Research Site

City

Aviano

ZIP/Postal Code

33081

Country

Italy

Facility Name

Research Site

City

Candiolo

ZIP/Postal Code

10060

Country

Italy

Facility Name

Research Site

City

Catania

ZIP/Postal Code

95123

Country

Italy

Facility Name

Research Site

City

Cremona

ZIP/Postal Code

26100

Country

Italy

Facility Name

Research Site

City

Genova

ZIP/Postal Code

16100

Country

Italy

Facility Name

Research Site

City

Lucca

ZIP/Postal Code

55100

Country

Italy

Facility Name

Research Site

City

Milano

ZIP/Postal Code

20132

Country

Italy

Facility Name

Research Site

City

Milano

ZIP/Postal Code

20133

Country

Italy

Facility Name

Research Site

City

Milano

ZIP/Postal Code

20141

Country

Italy

Facility Name

Research Site

City

Monza

ZIP/Postal Code

20900

Country

Italy

Facility Name

Research Site

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Research Site

City

Orbassano

ZIP/Postal Code

10043

Country

Italy

Facility Name

Research Site

City

Parma

ZIP/Postal Code

43100

Country

Italy

Facility Name

Research Site

City

Pisa

ZIP/Postal Code

56124

Country

Italy

Facility Name

Research Site

City

Rimini

ZIP/Postal Code

47900

Country

Italy

Facility Name

Research Site

City

Terni

ZIP/Postal Code

05100

Country

Italy

Facility Name

Research Site

City

Fukuoka-shi

ZIP/Postal Code

812-8582

Country

Japan

Facility Name

Research Site

City

Habikino-shi

ZIP/Postal Code

583-8588

Country

Japan

Facility Name

Research Site

City

Hidaka-shi

ZIP/Postal Code

350-1298

Country

Japan

Facility Name

Research Site

City

Hirakata-shi

ZIP/Postal Code

573-1191

Country

Japan

Facility Name

Research Site

City

Hirosaki-shi

ZIP/Postal Code

036-8545

Country

Japan

Facility Name

Research Site

City

Hiroshima-shi

ZIP/Postal Code

730-8518

Country

Japan

Facility Name

Research Site

City

Kanazawa

ZIP/Postal Code

920-8641

Country

Japan

Facility Name

Research Site

City

Kobe-shi

ZIP/Postal Code

650-0047

Country

Japan

Facility Name

Research Site

City

Kurume-shi

ZIP/Postal Code

830-0011

Country

Japan

Facility Name

Research Site

City

Matsuyama-shi

ZIP/Postal Code

791-0280

Country

Japan

Facility Name

Research Site

City

Nagoya-shi

ZIP/Postal Code

460-0001

Country

Japan

Facility Name

Research Site

City

Nagoya-shi

ZIP/Postal Code

464-8681

Country

Japan

Facility Name

Research Site

City

Nagoya-shi

ZIP/Postal Code

466-8560

Country

Japan

Facility Name

Research Site

City

Natori-shi

ZIP/Postal Code

981-1293

Country

Japan

Facility Name

Research Site

City

Okayama-shi

ZIP/Postal Code

700-8558

Country

Japan

Facility Name

Research Site

City

Osaka-shi

ZIP/Postal Code

541-8567

Country

Japan

Facility Name

Research Site

City

Osakasayama

ZIP/Postal Code

589-8511

Country

Japan

Facility Name

Research Site

City

Sakai-shi

ZIP/Postal Code

591-8555

Country

Japan

Facility Name

Research Site

City

Sapporo-shi

ZIP/Postal Code

003-0804

Country

Japan

Facility Name

Research Site

City

Sapporo-shi

ZIP/Postal Code

060-8648

Country

Japan

Facility Name

Research Site

City

Sendai-shi

ZIP/Postal Code

980-0873

Country

Japan

Facility Name

Research Site

City

Shinjuku-ku

ZIP/Postal Code

160-0023

Country

Japan

Facility Name

Research Site

City

Shinjuku-ku

ZIP/Postal Code

162-8655

Country

Japan

Facility Name

Research Site

City

Sunto-gun

ZIP/Postal Code

411-8777

Country

Japan

Facility Name

Research Site

City

Takatsuki-shi

ZIP/Postal Code

569-8686

Country

Japan

Facility Name

Research Site

City

Wakayama-shi

ZIP/Postal Code

641-8510

Country

Japan

Facility Name

Research Site

City

Yokohama-shi

ZIP/Postal Code

221-0855

Country

Japan

Facility Name

Research Site

City

Yokohama-shi

ZIP/Postal Code

236-0024

Country

Japan

Facility Name

Research Site

City

Busan

ZIP/Postal Code

49201

Country

Korea, Republic of

Facility Name

Research Site

City

Cheongju-si

ZIP/Postal Code

362-804

Country

Korea, Republic of

Facility Name

Research Site

City

Incheon

ZIP/Postal Code

405-760

Country

Korea, Republic of

Facility Name

Research Site

City

Jeonnam

ZIP/Postal Code

58128

Country

Korea, Republic of

Facility Name

Research Site

City

Seongnam-si

ZIP/Postal Code

13620

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

02841

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Research Site

City

Amsterdam

ZIP/Postal Code

1081 HV

Country

Netherlands

Facility Name

Research Site

City

Lublin

ZIP/Postal Code

20-362

Country

Poland

Facility Name

Research Site

City

Poznań

ZIP/Postal Code

60-569

Country

Poland

Facility Name

Research Site

City

Warszawa

ZIP/Postal Code

02-781

Country

Poland

Facility Name

Research Site

City

Alba Iulia

ZIP/Postal Code

510077

Country

Romania

Facility Name

Research Site

City

Baia Mare

ZIP/Postal Code

430031

Country

Romania

Facility Name

Research Site

City

Cluj Napoca

ZIP/Postal Code

400349

Country

Romania

Facility Name

Research Site

City

Cluj-Napoca

ZIP/Postal Code

400132

Country

Romania

Facility Name

Research Site

City

Onesti

ZIP/Postal Code

601048

Country

Romania

Facility Name

Research Site

City

Oradea

ZIP/Postal Code

410469

Country

Romania

Facility Name

Research Site

City

Timisoara

ZIP/Postal Code

300210

Country

Romania

Facility Name

Research Site

City

Arkhangelsk

ZIP/Postal Code

163045

Country

Russian Federation

Facility Name

Research Site

City

Omsk

ZIP/Postal Code

644013

Country

Russian Federation

Facility Name

Research Site

City

Saint Petersburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

Research Site

City

St. Petersburg

ZIP/Postal Code

197002

Country

Russian Federation

Facility Name

Research Site

City

St. Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Research Site

City

St. Petersburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

Research Site

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Research Site

City

Belgrad

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Research Site

City

Gornji Matejevac

ZIP/Postal Code

18204

Country

Serbia

Facility Name

Research Site

City

Kragujevac

ZIP/Postal Code

34000

Country

Serbia

Facility Name

Research Site

City

Sremska Kamenica

ZIP/Postal Code

21204

Country

Serbia

Facility Name

Research Site

City

Singapore

ZIP/Postal Code

119074

Country

Singapore

Facility Name

Research Site

City

Singapore

ZIP/Postal Code

169610

Country

Singapore

Facility Name

Research Site

City

Singapore

ZIP/Postal Code

308433

Country

Singapore

Facility Name

Research Site

City

A Coruña

ZIP/Postal Code

15006

Country

Spain

Facility Name

Research Site

City

Alicante

ZIP/Postal Code

03010

Country

Spain

Facility Name

Research Site

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

Facility Name

Research Site

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

Research Site

City

Girona

ZIP/Postal Code

17007

Country

Spain

Facility Name

Research Site

City

Jaén

ZIP/Postal Code

23007

Country

Spain

Facility Name

Research Site

City

Lleida

ZIP/Postal Code

25198

Country

Spain

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

08035

Country

Spain

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28005

Country

Spain

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28033

Country

Spain

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28050

Country

Spain

Facility Name

Research Site

City

San Sebastian

ZIP/Postal Code

20014

Country

Spain

Facility Name

Research Site

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Research Site

City

Sevilla

ZIP/Postal Code

41071

Country

Spain

Facility Name

Research Site

City

Valencia

ZIP/Postal Code

46014

Country

Spain

Facility Name

Research Site

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Research Site

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

Research Site

City

Taichung

ZIP/Postal Code

40705

Country

Taiwan

Facility Name

Research Site

City

Tainan

ZIP/Postal Code

704

Country

Taiwan

Facility Name

Research Site

City

Taipei City

ZIP/Postal Code

110

Country

Taiwan

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

116

Country

Taiwan

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

235

Country

Taiwan

Facility Name

Research Site

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

Research Site

City

Muang

ZIP/Postal Code

50200

Country

Thailand

Facility Name

Research Site

City

Phitsanulok

ZIP/Postal Code

65000

Country

Thailand

Facility Name

Research Site

City

Songkla

ZIP/Postal Code

90110

Country

Thailand

Facility Name

Research Site

City

Birmingham

ZIP/Postal Code

B15 2WB

Country

United Kingdom

Facility Name

Research Site

City

London

ZIP/Postal Code

EC1A 7BE

Country

United Kingdom

Facility Name

Research Site

City

London

ZIP/Postal Code

W1G 6AD

Country

United Kingdom

Facility Name

Research Site

City

Southampton

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

Facility Name

Research Site

City

Stevenage

ZIP/Postal Code

SG1 4AB

Country

United Kingdom

Facility Name

Research Site

City

Truro

ZIP/Postal Code

TR1 3LJ

Country

United Kingdom

Facility Name

Research Site

City

Wolverhampton

ZIP/Postal Code

WV10 0QP

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing URL

https://astrazenecagroup-dt.pharmacm.com/DT/Home

Citations:

PubMed Identifier

34056687

Citation

Martin ML, Correll J, Walding A, Ryden A. How patients being treated for non-small cell lung cancer value treatment benefit despite side effects. Qual Life Res. 2022 Jan;31(1):135-146. doi: 10.1007/s11136-021-02882-6. Epub 2021 May 31.

Results Reference

derived

PubMed Identifier

32201234

Citation

Planchard D, Reinmuth N, Orlov S, Fischer JR, Sugawara S, Mandziuk S, Marquez-Medina D, Novello S, Takeda Y, Soo R, Park K, McCleod M, Geater SL, Powell M, May R, Scheuring U, Stockman P, Kowalski D. ARCTIC: durvalumab with or without tremelimumab as third-line or later treatment of metastatic non-small-cell lung cancer. Ann Oncol. 2020 May;31(5):609-618. doi: 10.1016/j.annonc.2020.02.006. Epub 2020 Feb 20.

Results Reference

derived

Links:

URL

http://www.emergingmed.com/networks/AstraZeneca

Description

AstraZeneca Cancer Study Locator Service astrazeneca@emergingmed.com Phone number: 1-877-400-465

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=2584&filename=D4191C00004-sap-arctic-ed-3_Redacted.pdf

Description

Redacted SAP

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=2584&filename=D4191C00004-revised-csp-7_Redacted.pdf

Description

Redacted CSP

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A Global Study to Assess the Effects of MEDI4736 (Durvalumab), Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer (ARCTIC)

Non - Small Cell Lung Cancer NSCLC

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial